Introduction The iNedit Balloon Distal Access Catheter is a new type of thrombectomy device featuring a balloon catheter positioned 5cm from the tip, allowing for intracranial flow restriction while also enabling combined therapy with stent-retrievers and distal aspiration.
Aim of Study We investigate the appraisal of the use, safety, and efficacy of the iNedit catheter in vivo.
Methods In a multicentric study, prospective data was collected on 22 patients treated with the iNedit catheter to perform thrombectomy for acute ischemic stroke due to large vessel occlusion.
The outcome measures consisted of several evaluations of user experience rated on a 5-point scale ranging from 1(bad) to 5(excellent), as well as assessments of procedural safety outcomes such as artery perforation and arterial occlusion, procedural efficacy outcomes including first pass effect and final recanalization, and clinical efficacy outcomes such as a 3-month 0–2 mRS.
Results The mean age was 72±12 years old; median NIHSS was 17 (11−19); occlusion were 12 M1-MCA, 7 M2-MCA and 3 other. Median score evaluation of the appraisal of use was 4-IQR[4–5]. First pass complete recanalization rate was 50% (75% FPE in proximal M2 location), and the final recanalization rate (TICI 2b-3) was 90.9% of patients. No artery perforation and arterial occlusion. Good functional outcome mRS 0–2 was achieved in 50% of patients.
Conclusion In this initial clinical experience, the iNedit device achieved a high rate of first-pass effect and final recanalization rate with no safety concerns, thus favoring a high percentage of good clinical outcomes.
Disclosure of Interest Alejandro Tomasello has received personal fees from Anaconda Biomed, Balt, Medtronic, Perflow, and Stryker
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